Educational intervention to improve the inhalation technique in patients with chronic obstructive pulmonary disease (COPD)

ISRCTN	ISRCTN15106246
DOI	https://doi.org/10.1186/ISRCTN15106246
Protocol serial number	PI-0492/09 and EC10-193
Sponsor	Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)
Funder	Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)

Submission date: 23/03/2010
Registration date: 28/04/2010
Last edited: 19/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francisca Leiva Fernández
Scientific

Unidad Docente Medicina Familiar y Comunitaria
Distrito Sanitario Málaga
Plaza Hospital Civil s/n Pabellón 6 2ª planta
Málaga
29009
Spain

Phone	+34 951 29 03 10
Email	francisca.leiva.sspa@juntadeandalucia.es

Study information

Primary study design	Interventional
Study design	Multicentre patients' preference trial or comprehensive cohort design
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Efficacy of two educational interventions about inhalation technique in patients with chronic obstructive pulmonary disease (COPD): a preference study
Study acronym	TECEPOC
Study objectives	The application of two educational interventions in patients with chronic obstructive pulmonary disease (COPD) with inhaled therapy is going to improve in at least 25% the patients who perform a correct inhalation technique. Please note, as of 19/05/2011 a continuation of this trial has been implemented. The modifications to the trial can be found under the date of update in the relevant sections below. The anticipated end date has therefore been extended from 31/12/2011 to 30/06/2013.
Ethics approval(s)	1. Ethical Committee of Distrito Sanitario Málaga approved on the 1st March 2007 2. Ethical Committee of Distrito Sanitario Axarquía approved on the 13th May 2008
Health condition(s) or problem(s) studied	Chronic obstructive pulmonary disease (COPD)
Intervention	Current interventions (as of 19/05/2011) The study is divided into two groups and five arms. The two groups are: 1. The patients' preferences group (two arms) 2. The randomised group (three arms) In the preferences group, the two arms correspond to the two educational interventions designed for this study. In the randomised group, the three arms are as follows: Intervention A: Written information - We will give written information about inhalation technique to the patient. We will design a leaflet about the correct inhalation technique, containing the main devices the patients use in our area. Intervention B: Written information about inhalation technique and instructor training - We will give written information about inhalation technique to the patient (leaflet described above) and we are going to train the patient about correct inhalation technique. Control group: Treatment as usual. The appointments are approximately 20 - 30 minutes, depending on the arm of study. When the participant been located in an intervention arm the visit will be more detailed. The follow-up is the same for all arms and will be for 12 months. Visit schedule: Intervention Group A and B: Visit of inclusion: all the study data will be recorded and the inhalator technique will be tested Visit 1: It will take place 1 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied. Visit 2: I will take place 3 months after the intervention. all the study data will be recorded and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied. Visit 3: It will take place 6 months after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied. Visit 4: I will take place 12 months after the intervention. All the study data will be recorded and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied. Control Group: Visit of inclusion: all the study data will be recorded and the inhalator technique will be tested. Visit 1: It will take place 1 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured. Visit 2: I will take place 3 months after the intervention. All the study data will be recorded. Visit 3: It will take place 6 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured. Visit 4: I will take place 12 months after the intervention. All the study data will be recorded. Previous interventions: The study is divided into two groups and five arms. The two groups are: 1. The patients' preferences group (two arms) 2. The randomised group (three arms) In the preferences group, the two arms correspond to the two educational interventions designed for this study. In the randomised group, the three arms are as follows: Intervention A: Written information - We will give written information about inhalation technique to the patient. We will design a leaflet about the correct inhalation technique, containing the main devices the patients use in our area. Intervention B: Written information about inhalation technique and instructor training - We will give written information about inhalation technique to the patient (leaflet described above) and we are going to train the patient about correct inhalation technique. Control group: Treatment as usual. The appointments are approximately 20 - 30 minutes, depending on the arm of study. When the participant been located in an intervention arm the visit will be more detailed. The follow-up is the same for all arms and will be for 3 months. Visit schedule: Intervention Group A and B: Visit of inclusion: all the study data will be recorded and the inhalator technique will be tested Visit 1: It will take place 1 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied. Visit 2: I will take place 3 months after the intervention. all the study data will be recorded and encouraging work about inhalers techniques and motivational aspects related with this will be individually applied. Control Group: Visit of inclusion: all the study data will be recorded and the inhalator technique will be tested. Visit 1: It will take place 1 month after the intervention. Primary and secondary outcomes (not spirometry and quality of life) will be measured. Visit 2: I will take place 3 months after the intervention. All the study data will be recorded. Secondary Sponsor Details: Dirección General de Farmacia y Productos Sanitarios de Ministerio de Sanidad, Política Social e Igualdad. (Spain) Paseo del Prado 18-20 Madrid 28014 Spain +34 915961000 +34 915964480 oiac@mspsi.es http://www.msps.es
Intervention type	Other
Primary outcome measure(s)	Performance of correct inhalation technique. The correct inhalation technique will be measured by an investigator following SEPAR guidelines. Measured at all visits
Key secondary outcome measure(s)	Current secondary outcomes measures (as of 19/05/2011): 1. Pick flow, measured at all visits 2. Dyspnoea (Baseline Dyspnoea Index [IDB] and Modified Medical Research Council [MMRC] questionnaires), measured at all visits 3. Functional status (spirometry), measured at visit of inclusion, visit 2 and visit 4. 4. Quality of life, measured with the Spanish version of the St George's Respiratory Questionnaire and the specifically created SeguiEPOC Questionnaire, measured at visit of inclusion, visit 2 and visit 4. Previous secondary outcome measures: 1. Pick flow, measured at all visits 2. Dyspnoea (Baseline Dyspnoea Index [IDB] and Modified Medical Research Council [MMRC] questionnaires), measured at all visits 3. Functional status (spirometry), measured at visit of inclusion and visit 2 4. Quality of life, measured with the Spanish version of the St George's Respiratory Questionnaire and the specifically created SeguiEPOC Questionnaire, measured at visit of inclusion and visit 2
Completion date	30/06/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	495
Key inclusion criteria	1. Confirmed COPD diagnose by spirometry (Spanish Society of Pulmonology and Thoracic Surgery [SEPAR] guidelines) 2. Belonging to the selected Primary Care Centres in Malaga area 3. Use of inhalatory therapy 4. Accepted to participate in the study and gives informed consent 5. Aged greater than or equal to 18 years, either sex
Key exclusion criteria	1. Diagnosis of other respiratory conditions which are not included in the COPD definition 2. Cognitive impairment problems
Date of first enrolment	15/03/2010
Date of final enrolment	30/06/2013

Locations

Countries of recruitment

Spain

Study participating centre

Unidad Docente Medicina Familiar y Comunitaria

Málaga
29009
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes